| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 17290110121676 | 1 | AAIR02031605 | ILY,GEX | Lamp, Infrared, Therapeutic Heating,Powered Laser Surgical Instrument | 2 | NIR Module | |
| 2 | 17290110120662 | 1 | AAHR01080402 | GEX | Powered Laser Surgical Instrument | 2 | Diode 810nm Handpiece for Soprano | |
| 3 | 17290110120136 | 1 | AAAC08120801 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | SPA RF Unibody HP | |
| 4 | 17290110121652 | 1 | AASP30111205 | ILY,GEX | Lamp, Infrared, Therapeutic Heating,Powered Laser Surgical Instrument | 2 | Diode 810nm2 cm2 HP | |
| 5 | 17290110121614 | 1 | AASR11021407 | NUV,ISA | Massager, Vacuum, Light Induced Heating,Massager, Therapeutic, Electric | 1 | Unipolar HP | |
| 6 | 17290110122222 | 1 | AACL25102199 | GEX,FTC,HHR,LNK | Powered Laser Surgical Instrument,Light, Ultraviolet, Dermatological,Laser, Surg Powered Laser Surgical Instrument,Light, Ultraviolet, Dermatological,Laser, Surgical, Gynecologic,Laser For Gastro-Urology Use | 2 | Tip ClearLift QS 5x5 without Depth Control Set (Female) | |
| 7 | 17290110122185 | 1 | AACL03052002 | Opus Colibri 1mm Single-use Tip one unit | GEI,NUV,ISA,IMI | Electrosurgical, Cutting & Coagulation & Accessories,Massager, Vacuum, Light Ind Electrosurgical, Cutting & Coagulation & Accessories,Massager, Vacuum, Light Induced Heating,Massager, Therapeutic, Electric,Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | Opus Colibri 1mm Single-use Tip (X1) |
| 8 | 17290110122048 | 1 | AACO28111920 | 24 pc's in package | HQF,GEX | Laser, Ophthalmic,Powered Laser Surgical Instrument | 2 | FemiLift Slim Sleeve 24 |
| 9 | 17290110121454 | 1 | AAIP05041504 | ILY,ONF | Lamp, Infrared, Therapeutic Heating,Powered Light Based Non-Laser Surgical Instr Lamp, Infrared, Therapeutic Heating,Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | Nir Handpiece (6cm) | |
| 10 | 17290110121379 | 1 | AADR03011204WA0002 | GEX | Powered Laser Surgical Instrument | 2 | Handpiece QS High Power For Harmony XL 1200J (100-120V) | |
| 11 | 17290110121188 | 1 | QTL-MYDON-24071201 | GEX | Powered Laser Surgical Instrument | 2 | MYDON Nd:YAG Laser System | |
| 12 | 17290110120990 | 1 | AASP15091002 | GEX | Powered Laser Surgical Instrument | 2 | Soprano XLi System 110V (Black) | |
| 13 | 17290110120556 | 1 | AAIP25121107 | ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | Nir Handpiece For Harmony Lite System (18cm) | |
| 14 | 17290110120457 | 1 | AAIP09070709 | GEX | Powered Laser Surgical Instrument | 2 | Handpiece Harmony/Aria (E) 650 HR | |
| 15 | 17290110120440 | 1 | AAIP09070706 | GEX | Powered Laser Surgical Instrument | 2 | Handpiece Harmony/Aria (E) 570 SR | |
| 16 | 17290110120242 | 1 | AAUN27121001 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Ultra V Unilarge Thermometer Handpiece | |
| 17 | 17290110120150 | 1 | AAUN27091203 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Accent Vshape Pixel RF Handpiece 110V (Alma Inc) | |
| 18 | 17290110120051 | 1 | AATE15031202 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Accent XLi Unibody HP | |
| 19 | 17290110120037 | 1 | AATE17010802 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Accent XL Unipolar HP 1 | |
| 20 | 17290110122246 | 1 | AACL02062120 | FTC,GEX,HHR,LNK | Light, Ultraviolet, Dermatological,Powered Laser Surgical Instrument,Laser, Surg Light, Ultraviolet, Dermatological,Powered Laser Surgical Instrument,Laser, Surgical, Gynecologic,Laser For Gastro-Urology Use | 2 | Tip ClearLift QS CVD (Female) | |
| 21 | 17290110122161 | 1 | AACL03052003 | Opus Colibri 1mm Single-use Tip Set of 6 units | GEI,NUV,ISA,IMI | Electrosurgical, Cutting & Coagulation & Accessories,Massager, Vacuum, Light Ind Electrosurgical, Cutting & Coagulation & Accessories,Massager, Vacuum, Light Induced Heating,Massager, Therapeutic, Electric,Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | Opus Colibri 1mm Single-use Tip Set (X6) |
| 22 | 17290110122116 | 1 | AACO05111960 | ProScan Applicator for Hybrid System | GEX | Powered Laser Surgical Instrument | 2 | ProScan Applicator for Hybrid System |
| 23 | 17290110122109 | 1 | AACO15061980BDAZ0003 | Hybrid System 70W 120V 50/60 HZ | GEX | Powered Laser Surgical Instrument | 2 | Hybrid System 70W 120V 50/60 HZ |
| 24 | 17290110122086 | 1 | AASP12091714 | (includes Glide Disposable Tip Set (X12) & Opus Plasma Tip Kit) | GEI,NUV,ISA,IMI | Electrosurgical, Cutting & Coagulation & Accessories,Massager, Vacuum, Light Ind Electrosurgical, Cutting & Coagulation & Accessories,Massager, Vacuum, Light Induced Heating,Massager, Therapeutic, Electric,Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | Opus Plasma Applicator |
| 25 | 17290110122024 | 1 | AACO28111918 | HQF,GEX | Laser, Ophthalmic,Powered Laser Surgical Instrument | 2 | FemiLift Slim Sleeve 1 | |
| 26 | 17290110121478 | 1 | AAQS02071550 | GEX | Powered Laser Surgical Instrument | 2 | Collimated HP | |
| 27 | 17290110121409 | 1 | AASP10121401 | ILY,GEX | Lamp, Infrared, Therapeutic Heating,Powered Laser Surgical Instrument | 2 | Diode 1064nm Compact For Soprano | |
| 28 | 17290110121393 | 1 | AASP13021206 | GEX | Powered Laser Surgical Instrument | 2 | Soprano Ice System 220V | |
| 29 | 17290110121331 | 1 | AAVC05051602 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Accent Pro Vacuum HP Periorbital | |
| 30 | 17290110121300 | 1 | AADS03021302 | GEX | Powered Laser Surgical Instrument | 2 | Alma VascuLife Diode System 1470 110V | |
| 31 | 17290110121164 | 1 | QTL-EXELO2-11071201 | ONG | Powered Laser Surgical Instrument With Microbeam\Fractional Output | 2 | EXELO2 CO2 Laser System | |
| 32 | 17290110120891 | 1 | AAHX03051201 | GEX | Powered Laser Surgical Instrument | 2 | Harmony XL System Black 110V | |
| 33 | 17290110120853 | 1 | AASP13031301 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Spa RF HD3D Dielectric System 120V (white) | |
| 34 | 17290110120716 | 1 | AASP24081303 | GEX | Powered Laser Surgical Instrument | 2 | Diode Alex 755nm 1.5cm HP Soprano Ice & Xli | |
| 35 | 17290110120709 | 1 | AASP18021510 | GEX | Powered Laser Surgical Instrument | 2 | Diode 810nm Speed HP For Soprano Pontiac White | |
| 36 | 17290110120617 | 1 | AASP19121301 | GEX | Powered Laser Surgical Instrument | 2 | Diode 810nm Compact For Soprano Ice & Xli (New) | |
| 37 | 17290110120549 | 1 | AADR03011201 | GEX | Powered Laser Surgical Instrument | 2 | Handpiece QS High Power For Harmony XL KJ Counts (with CVD) N/A | |
| 38 | 17290110120518 | 1 | AAIP24110810 | GEX | Powered Laser Surgical Instrument | 2 | Handpiece LP cooled 1064 YAG for Harmony XL | |
| 39 | 17290110120433 | 1 | AAIP09070705 | GEX | Powered Laser Surgical Instrument | 2 | Handpiece Harmony/Aria (E) 540 VL/PL | |
| 40 | 17290110120334 | 1 | AAIP25121103 | GEX | Powered Laser Surgical Instrument | 2 | Handpiece Cooled Dye VL (3) For Lite Pro | |
| 41 | 17290110120266 | 1 | AAHP01050802 | GEX | Powered Laser Surgical Instrument | 2 | Handpiece Cooled 540 (3) for Harmony XL 50000 pulses | |
| 42 | 17290110120235 | 1 | AAUN27121005 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Ultra V Uniface Handpiece | |
| 43 | 17290110120204 | 1 | AAUN27121004 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Ultra V UltraBody Handpiece | |
| 44 | 17290110120181 | 1 | AAUN27121002 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Ultra V Bipolar Thermometer Handpiece | |
| 45 | 17290110120082 | 1 | AASR07031307 | NUV | Massager, Vacuum, Light Induced Heating | 2 | Accent Elite II Pixel RF HP 110V (Alma Inc) | |
| 46 | 17290110120013 | 1 | AATE28070804 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Accent XL Unibody HP | |
| 47 | 17290110121690 | 1 | AAUL25101702 | NUV,ISA,IMI | Massager, Vacuum, Light Induced Heating,Massager, Therapeutic, Electric,Ultrason Massager, Vacuum, Light Induced Heating,Massager, Therapeutic, Electric,Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | Mini Speed HP | |
| 48 | 17290110121607 | 1 | AASR11021401 | NUV,ISA | Massager, Vacuum, Light Induced Heating,Massager, Therapeutic, Electric | 1 | Bipolar HP | |
| 49 | 17290110122277 | 1 | AAER05062120 | GEX,FTC,HHR,LNK | Powered Laser Surgical Instrument,Light, Ultraviolet, Dermatological,Laser, Surg Powered Laser Surgical Instrument,Light, Ultraviolet, Dermatological,Laser, Surgical, Gynecologic,Laser For Gastro-Urology Use | 2 | Tip ClearLift QS Scanner 5x5 & CVD (Female) | |
| 50 | 17290110122239 | 1 | EGGG29112199 | GEX,FTC,HHR,LNK | Powered Laser Surgical Instrument,Light, Ultraviolet, Dermatological,Laser, Surg Powered Laser Surgical Instrument,Light, Ultraviolet, Dermatological,Laser, Surgical, Gynecologic,Laser For Gastro-Urology Use | 2 | ClearLift Depth Control Set for ClearLift QS 5x5 (No Lasing Tip) Female |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 03830054230996 | M002-6A/2 PRO | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | LightWalker ST-E PRO | FOTONA D.O.O. | |
| 2 | 03830054230897 | M002-6A/2 ADVANCED | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker ST-E ADVANCED | FOTONA D.O.O. | |
| 3 | 03830054230798 | M021-5AF/2 ADVANCED | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker DT ADVANCED | FOTONA D.O.O. | |
| 4 | 03830054230699 | M021-5AF/1 S | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic anddermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker AT S | FOTONA D.O.O. | |
| 5 | 03830054230590 | M002-6A/2 STAND | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker ST-E STAND | FOTONA D.O.O. | |
| 6 | 03830054230514 | M002-6A/2 | The device and its accessories are intended to be used in the fields of dentistr The device and its accessories are intended to be used in the fields of dentistry, aesthetics, dermatology, gynecology and urology, ENT, surgery and pain management. | TimeWalker ST-E | FOTONA D.O.O. | |
| 7 | 03830054230507 | M021-5AF/1 | The device and its accessories are intended to be used in the fields of dentistr The device and its accessories are intended to be used in the fields of dentistry, aesthetics, dermatology, gynecology and urology, ENT, surgery and pain management. | TimeWalker AT | FOTONA D.O.O. | |
| 8 | 03830054230491 | M021-5AF/2 STAND | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that opehttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageDataLoaded=false&pageMode=create#rates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery | Lightwalker DT STAND | FOTONA D.O.O. | |
| 9 | 03830054230484 | M031-3A/2 PQX | The Fotona StarWalker PQX laser system and its accessories are intended for tatt The Fotona StarWalker PQX laser system and its accessories are intended for tattoo removal, treatment of pigmented lesions and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue, and ablation and vaporization of soft tissue in general dermatology. | StarWalker | FOTONA D.O.O. | |
| 10 | 03830054230408 | M321-B | The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attac The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen. | SkyPulse | FOTONA D.O.O. | |
| 11 | 03830054230392 | M321-A | The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attac The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen. | SkyPulse | FOTONA D.O.O. | |
| 12 | 03830054230354 | M031-3A/2 QX | The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are intended for tattoo removal, treatment of pigmented and vascular lesions, surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue, and incision/excision, ablation and vaporization ofsoft tissue in general dermatology. | StarWalker | FOTONA D.O.O. | |
| 13 | 03830054230347 | M002-6A/2 ADVANCED | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | LightWalker ST-E ADVANCED | FOTONA D.O.O. | |
| 14 | 03830054230330 | M031-3A/2 MAQX | The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are intended for tattoo removal, treatment of pigmented and vascular lesions, surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue, and incision/excision, ablation and vaporization ofsoft tissue in general dermatology. | StarWalker | FOTONA D.O.O. | |
| 15 | 03830054230293 | M002-6A/2 | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker ST-E | FOTONA D.O.O. | |
| 16 | 03830054230231 | M001-14F 2 | "The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the "The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which is available in a table-top version or mobile version with an undercarriage that provides additional storage space. All laser systems within the family incorporate a treatment laser that operates in the invisible, near-infrared range of the electromagnetic spectrum and an aiming laser that operates in the visible range.XP Focus family laser systems incorporate:· A Nd:YAG laser source operating at a wavelength of 1064 nm in PULSE and Quasi Continuous Wave (QCW) mode of operation.· An aiming semiconductor diode laser operating at a wavelength of 650 nm.The Variable Square Pulse (VSP) Technology incorporated in the laser systems provides control of laser energy and laser pulse length." | Fotona XP-2 Focus | FOTONA D.O.O. | |
| 17 | 03830054230224 | M001-14F 1 | The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the X The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which is available in a table-top version or mobile version with anundercarriage that provides additional storage space. All laser systems within the family incorporate a treatment laser that operates in the invisible, near-infrared range of the electromagnetic spectrum and an aiming laser that operates in the visible range.XP Focus family laser systems incorporate:· A Nd:YAG laser source operating at a wavelength of 1064 nm in PULSE and Quasi Continuous Wave (QCW) mode of operation.· An aiming semiconductor diode laser operating at a wavelength of 650 nm.The Variable Square Pulse (VSP) Technology incorporated in the laser systems provides control of laser energy and laser pulse length. | Fotona XP Focus | FOTONA D.O.O. | |
| 18 | 03830054230217 | M001-12F | The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, aswell as an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery. | XP Spectro | FOTONA D.O.O. | |
| 19 | 03830054230200 | M021-4AF/3 | "The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in "The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, as well as an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery." | SP Spectro | FOTONA D.O.O. | |
| 20 | 03830054230194 | M021-5AF/1 | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range.The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic anddermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker AT | FOTONA D.O.O. | |
| 21 | 03830054230170 | M001-14F | The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the X The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which is available in a table-top version or mobile version with anundercarriage that provides additional storage space. All laser systems within the family incorporate a treatment laser that operates in the invisible, near-infrared range of the electromagnetic spectrum and an aiming laser that operates in the visible range.XP Focus family laser systems incorporate:· A Nd:YAG laser source operating at a wavelength of 1064 nm in PULSE and Quasi Continuous Wave (QCW) mode of operation.· An aiming semiconductor diode laser operating at a wavelength of 650 nm.The Variable Square Pulse (VSP) Technology incorporated in the laser systems provides control of laser energy and laser pulse length. | Fotona XP Focus | FOTONA D.O.O. | |
| 22 | 03830054230163 | M001-12F | The Fotona XP Max (DualisXP Plus II) laser system incorporates a treatment laser The Fotona XP Max (DualisXP Plus II) laser system incorporates a treatment laser that operates in the invisible near-infrared range of the electromagnetic spectrum, and an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology implemented in the laser systems allows ultimate control of laser energy and laser pulse length.The Fotona XP Max (DualisXP Plus II) laser system incorporates the following laser sources:· A long-pulse Nd:YAG laser, with a wavelength of 1064 nm· An aiming beam diode laser, with a wavelength of 650 nmThe Fotona XP MAX (DualisXP Plus II) Nd:YAG laser system and its accessories is indicated for use in surgical and aesthetic applications requiring the selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology. | Fotona XP Max | FOTONA D.O.O. | |
| 23 | 03830054230125 | M002-2A | The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, aswell as an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery. | XS Dynamis | FOTONA D.O.O. | |
| 24 | 03830054230118 | M001-12F | The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, aswell as an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery | XP Dynamis | FOTONA D.O.O. | |
| 25 | 03830054230101 | M021-4AF/3 | The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, aswell as an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery. | SP Dynamis | FOTONA D.O.O. | |
| 26 | 03830054230095 | M021-5AF/2 | "The Fotona LightWalker laser system range incorporates treatment lasers that op "The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. " | Lightwalker DT | FOTONA D.O.O. | |
| 27 | 03830054230064 | M031-3A/2 | The Fotona QX laser system family incorporates a treatment laser that operates i The Fotona QX laser system family incorporates a treatment laser that operates in the invisible mid-infrared and visible range of the electromagnetic spectrum.Variable Square Pulse (VSP) Technology implemented in the laser systems allows ultimate control of laser energy and laser pulse length.The Fotona QX MAX laser system and its accessories are intended for tattoo removal, treatment of pigmented and vascular lesions, surgical and aestheticapplications requiring selective photothermolysis of target chromophores in soft tissue, and incision/excision, ablation and vaporization of soft tissue in generaldermatology. | Fotona QX Max | FOTONA D.O.O. | |
| 28 | 03760313461017 | EIPL-100 | EIPL-PRD-K01-exci308 | Exci308® by AerolaseThis medical device is intended to be used for the treatment Exci308® by AerolaseThis medical device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.Excimer light source, wavelength 308nm, optical power 2500 mW. | EXCI308 by Aerolase | CLARTEIS |
| 29 | 03760313461000 | EIPL-100 | EIPL-PRD-K01-(US) | Exciplex® set - USAThis medical device is intended to be used for the treatment Exciplex® set - USAThis medical device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.Excimer light source, wavelength 308nm, optical power 2500 mW. | Exciplex® | CLARTEIS |
| 30 | 03760227850198 | SK+-EO-980-25-600-3 | STERILE MEDICAL HANDPIECE FOR SINGLE USE | SMOOTHKIT+ | LSO MEDICAL | |
| 31 | 03760227850174 | OSYHAND | STERILE MEDICAL HANDPIECE FOR SINGLE USE | OSYHAND | LSO MEDICAL | |
| 32 | 03760227850150 | PH-EO-980-25-600-3 | STERILE MEDICAL OPTICAL FIBER FOR SINGLE USE | OSYFIBRE | LSO MEDICAL | |
| 33 | 03700542625569 | VITRA 2 | The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is inte The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. | VITRA 2 | QUANTEL MEDICAL | |
| 34 | 03700542625415 | VMS | 532nm Multispot LaserRetinal Photocoagulation | VITRA MULTISPOT | QUANTEL MEDICAL | |
| 35 | 03700542625309 | SUPSC532OPT | SUPRASCAN 532nm adaptor for OPTIMIS II (MultiSpot) | SUPRASCAN 532nm for OPTIMIS II | QUANTEL MEDICAL | |
| 36 | 03700542625293 | SUPSC532 | 532nm adaptor for HS900 BM/BQ Slit Lamp (MultiSpot) | SUPRASCAN 532nm | QUANTEL MEDICAL | |
| 37 | 03662824000207 | D029AF001C08A | E>EYE C | E-SWIN | ||
| 38 | 011000009 | AL 10000 V400 7 Series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 39 | 011000008 | AL 10000 V400 XL 7 series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 40 | 011000007 | AL 10000 V7 7 Series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 41 | 011000006 | AL 10000 V700 XL | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 42 | 011000005 | AL 10000 V700 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 43 | 011000004 | AL 10000 V400XL | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 44 | 011000002 | AL10000 V400 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 45 | 010822603 | AL 8000 Ultra Plus 7 Series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 46 | 010822602 | AL 8000 Ultra Plus | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 47 | 010800004 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 48 | 010800003 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 49 | 010800002 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 50 | 010800001 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. |